Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first and largest cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
The FHCRC Quality Assurance department (“QA”) oversees compliance with the Food and Drug Administration’s cGMP, current Good Tissue Practices (cGTP) and other applicable regulations as they apply to the manufacturing and testing of pre-clinical, Phase I and Phase II biologic and cell and gene therapy products. The QA Manager/Sr. Manager, reporting to the Head of Quality for the Therapeutic Products Program will ensure timely completion of batch record review, SOP revision, deviation management and tracking along with hosting and performing external and vendor audits.
The Quality Assurance Manager will primarily support the Biologics Production facility operations, but also continue to develop the established quality systems for the cellular processing facility. In addition, this position will lead and champion quality system integration between the CPF and BPF. The QA manager will interact with manufacturing personnel in the GMP Biologics Production Facility and the Cellular Processing Facility, research scientists, physician investigators, process development, Quality Control, and other scientific staff and external collaborators. The incumbent will be expected to work with project teams as a quality representative to support clinical development programs. In addition, the individual will work with project teams to ensure clinical studies and supporting activities are conducted in compliance with GxP.